Standardisation of Single-Use Technologies with Janssen Biologics

Ciaran Kelleher is Principal Engineer with Global Technical Services within Janssen Supply Chain. He will be speaking on the topic of standardisation of single-use technologies at the upcoming Disposables Solutions for Bio-Manufacturing conference which is taking place in Brussels between 19th and 20th February. He talks about the most important developments in pharma technology.

Pharma IQ: What are the current challenges around standardisation of single use components?

C Kelleher: From our perspective, we view standardisation in two quite distinct buckets. Firstly we look at standardisation as it's applied by the various component and assembly manufacturers and then we look at the standardisation of single-use technologies as we as a company and user would apply them within the operations.

In the case of the former, I think the main challenges are the lack or limited harmonisation of common standards that we can see across components. So issues like dimensions, some aspects on materials, testing and documentation, are areas which could be considered. For the likes of tri-clamp connectors and hose barbs, we all have experienced a certain amount of variability and issues with those in the past.

Documentation is also another area and the data contained within those; we’d like to see more harmonisation or standardisation around this. It would make life easier for the end user in terms of candidate selection or doing the initial assessment on potential new components. But also be of benefit to the actual manufacturers and assemblers themselves as it would limit the amount of bespoke requirements and customisation that they may be experiencing from clients. So a certain amount of dialogue might be able to set up the standards there, reduce the number of permutations and combinations that you might have around those.

Pharma IQ: Can you share some tips on strategies that you're implementing to combat the challenges around standardisation?

C Kelleher: We've adopted quite an amount of single-use technology, particularly in the case of bags for product, media and buffer; tubing and filter assemblies. We have also implemented use single use bioreactors. Depending on the products and the applications we ended up having bespoke systems on a case by case application. We’ve started to break those into smart elements, so separate bags from filters using aseptic connectors. It means we can have a smaller portfolio of filters and bags depending on what the product and application is going to be.

And similarly with regard to general tubing assemblies, bag assemblies that we may have on a process stream, we are trying to break those down into key units and groups which may be configured to meet current and future manufacturing needs and product introductions. We are trying to future-proof our range of components and assemblies.

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Pharma IQ: How is standardisation best achieved?

C Kelleher: There's no doubt that a lot of companies are effectively looking internally at opportunities for which they can standardise their single-use applications. Equally there's a lot of external forums, like BPOG and ASME BPE and these groups are also looking at similar issues. So you're getting quite a lot of sharing of information between companies which is not necessarily be proprietary.

I think this can allow for the development of standard platforms within the industry and these initiatives really should continue on and be supported. Equally, vendors on the whole are extremely cooperative when it comes to working with end users and really collaborating with them to help on a standardisation process.
Pharma IQ: What will be the main goals of Janssen Biologicals in this area in 2013?

C Kelleher: The main goals that we're looking at within the Janssen supply chain for 2013 when it comes to single-use technologies and disposables is to continue to work on our approach leachable and extractable procedures and methodologies and our approvals process. This can be spread over several aspects of the network in different divisions and different groups, so there have been quite a significant number of stakeholders involved in that.

We’re also looking at ways of improving communication, and using that process to see if we can leverage from our experiences and the ongoing work that we have across different sites and internal companies. We also want to develop better strategies when it comes to planning for work for expanding our single-use portfolio and trying to collaborate more across different divisions of Johnson & Johnson.

Pharma IQ: Can you explain the work you are doing around supply chain reliability?

C Kelleher: Supply chain reliability is an area we have been aware of and we have been working on for the past number of years. In the case of single-use, we're continuing to work on strategies for dual source for components which would have minimal impact upon our operations and equipment. That's something that we're rolling out on our site in Cork. It has proved successful and I would expect that's what we’re going to continue throughout the rest of the supply chain as time progresses.

But there are challenges in regards to supply chain reliability. Janssen is anxious to have a robust leachables and extractables assessment mechanism, which will effectively address vendor change management. We need to ensure we have a clear understanding of how our various products and processes might be impacted by seemingly innocuous changes. For that reason, I suppose, we would consider that a key risk, I think, when it comes to using single use for manufacturing operations.
Pharma IQ; Have you got a defined waste management strategy at Janssen?

C Kelleher: Yes, we have a strategy for the management of our waste here onsite. I suppose with the increasing use of single-use that's something that we're continuing to develop. Currently we're trialling a process whereby our single-use components are collected onsite. We basically do preliminary inactivation treatment to mitigate against any biological agent or biological contamination aspect of it. And following that treatment we’re currently dealing with an external company who effectively use those polymeric and elastomeric components as part of a fuel manufacturing process. So that's currently an initiative that is undergoing an evaluation, and hopefully over the coming months we'll have a better understanding as to whether this is something we can progress with.

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